MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY TIR-1 THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 38581

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.External visual inspection found no damage.The device powered on and off using customer and lab stock batteries.Temperature accuracy testing was performed via blackbody water bath temperature verification.During testing, the temperature readings were low and outside specification.The external surface of the ir sensor lens was cleaned, and device accuracy was retested.The additional testing resulted in low temperature readings.The customer complaint was duplicated.Temperature measurements are outside specification.A service history record review reveals that this unit was in the field for over two (2) months with no previous reported issues related to this reported event.

Event Description

The customer reported the device is reading lower than it should.No patient impact or consequences were reported.

• Brand Name: TIR-1 THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 52 discovery; irvine, CA 92618 ; 9496978262
• MDR Report Key: 11141652
• MDR Text Key: 227597364
• Report Number: 3011353843-2021-00008
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K131771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 38581
• Device Catalogue Number: 4301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1